Glossary
Labeling Control
Control of the whole path by which labelling and packaging materials are received, stored, issued, and used, with the records kept in the batch record.
Details
Even where the product itself is sound, wrong labelling means the patient gets a different medicine, so the United States regulation groups labelling and packaging materials into their own subpart. Almost every finding in the corpus takes the form of 21 CFR 211.188(b)(8): the batch record lacked the control records including specimens or copies of the labelling used. Also check whether obsolete and outdated labelling was destroyed (211.122(e)) and whether special control such as dedicated lines or examination of every unit was in place to prevent mix-ups between similar products (211.122(g)).
